(28 days)
The EVA15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.
The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is indicated to facilitate the use of various endoscopic instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 Insufflator is used in an operating room or endoscopic suite. It consists of the following major components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a disposable tube set.
There are 3 operating modes:
- (a) Continuous Flow (similar to a traditional endoscopic insufflator) delivers a fixed flow between 0 and 15 standard liters per minute (SLPM)
- (b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) a pressure is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- (c) Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).
The tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation respectively.
The provided text is a 510(k) summary for the EVA15 Insufflator. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria, especially in an AI/software context.
This document is for a medical device (insufflator), not an AI/software device. The regulatory filings for traditional medical devices like this typically focus on demonstrating substantial equivalence to a predicate device through engineering specifications, performance testing (often physical and bench testing), and adherence to recognized standards, rather than clinical studies with human readers or AI performance metrics.
Therefore, I cannot extract the requested information in the format provided because it is not present in the document. The document explicitly states:
- "As the subject device is identical in design to the predicate, performance data from the predicate device were leveraged to support the performance of the subject device." This indicates that no new performance study was conducted for this specific 510(k) submission, as the design is unchanged from the predicate.
- The comparison table focuses on physical characteristics, operating modes, and basic performance parameters (flow, pressure range), not on metrics like sensitivity, specificity, or reader improvement with AI.
In summary, the provided text does not contain any information relevant to acceptance criteria and studies for an AI/software device. This type of document would not typically include the details requested in your prompt.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.